BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VACUETTE QUICKSHIELD COMPLETE PLUS 21GX1'' SP

    MDR report key: 10446197 · Received August 24, 2020

    Report

    Report Number
    8020040-2015-00026
    Event Type
    Malfunction
    Date Received
    August 24, 2020
    Report Date
    August 24, 2020
    Manufacturer
    GREINER BIO-ONE GMBH
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    GBO COMPLAINT: (B)(4). RECEIVED 13PCS 450235/G141235R FOR EVALUATION. THE ACTUAL SAMPLE WERE NOT RECEIVED. WE HAVE NO FURTHER COMPLAINTS ON THE MATERIAL/BATCH. WE FORWARDED THE COMPLAINT AND SAMPLES TO OUR AFFILIATED HEADQUARTER FROM WHICH WE RECEIVED THIS PRODUCT. THE CUSTOMER RETURNED SAMPLES WERE VISUALLY INSPECTED AND FUNCTIONALLY TESTED ACCORDING TO GBO INTERNAL PROCEDURES AND INSTRUCTION FOR USE., NO DEVIATION WERE DETECTED. A REVIEW OF PRODUCTION AND TESTING DOCUMENTS INDICATES NO DEVIATION OCCURRED DURING PRODUCTION. NO ABNORMALITIES DETECTED DURING IN PROCESS CONTROL. DOCUMENTS FOR THE BATCH FINAL CHECKING, WHICH INCLUDES FUNCTIONAL TESTING, INDICATE THAT NO ABNORMALITIES WERE DOCUMENTED. THEREFORE, THIS CAN NOT BE CONFIRMED.

    Description of Event or Problem · 1

    CUSTOMER STATES THAT ON TWO OCCASIONS THE NEEDLE DISLODGED FROM THE HOLDER DURING ACTIVATION OF THE SAFETY. THE NEEDLES REMAINED INTACT. NO INJURIES OR BLOOD EXPOSURES OCCURRED AS A RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    911037 VACUETTE QUICKSHIELD COMPLETE PLUS 21GX1'' SP NEEDLE, HYPODERMIC, SINGLE LUMEN FMI GREINER BIO-ONE GMBH 450235 450235

    Patients

    Seq Age Sex Outcome Treatment
    1